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Drug Safety Newsletter – Edition 119 – 09 June 2025

09/06/2025
Medicines for human use Safety update

The latest edition of the HPRA newsletter includes important updates to support the safe and appropriate use of the following medicines:

  • Finasteride and dutasteride: Outcome of EU review regarding risk of suicidal ideation
  • Bilastine oral formulations: New warning on the risk of QT prolongation/Torsade de points
  • Azathioprine: Update to warning on hepatotoxicity and monitoring
  • Mesalazine: New warning regarding the risk of idiopathic intracranial hypertension

Documents

Opens in new window Drug Safety Newsletter Issue 119 June 2025 PDF : 170KB | 09/06/2025